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Neurim Pharmaceuticals Achieves Major Milestone with EU Approval of Slenyto®

In a groundbreaking development, Neurim Pharmaceuticals, headquartered in Tel Aviv, has received approval from the European Commission for its product Slenyto®. This approval specifically extends the medication’s use to treat sleep disorders in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). This marks a significant milestone not only for the company but also for the thousands of families dealing with sleep disturbances linked to ADHD.

Background on Slenyto®

Slenyto® is a pediatric formulation of melatonin designed for extended release, which was originally approved in the EU back in 2018. Its initial indication was for treating sleep disorders in children with Autism Spectrum Disorder (ASD) or Smith-Magenis Syndrome (SMS). After its efficacy was established within these populations, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended its expansion to include neurogenetic disorders and now, ADHD. Notably, Slenyto® is the first medication approved specifically for sleep disorders among these conditions.

The Need for Effective Treatments

Research indicates that sleep disorders are prevalent in children with ADHD, affecting approximately 70% of this population. These sleep issues can exacerbate core ADHD symptoms, leading to increased daytime sleepiness and a reduction in the overall quality of life for both the affected children and their caregivers. With sleep hygiene measures often insufficient, there has been a pressing need for pharmacological solutions.

Neurim Pharmaceuticals emphasizes the importance of Slenyto® in addressing this gap, as stated by Professor Nava Zisapel, CEO of the company. The approval reflects a commitment to meeting the needs of families seeking effective treatments for ADHD-related sleep challenges.

Mechanism of Action and Benefits

Slenyto® mimics the natural melatonin secretion pattern found in healthy individuals, which can help to regulate sleep-wake cycles effectively. This prolonged-release formulation releases melatonin throughout the night, addressing both the onset of sleep and the maintenance of continuous sleep. The unique characteristics of Slenyto® are especially beneficial for children who have difficulties producing sufficient melatonin endogenously.

Healthcare professionals like Dr. Carmen Schroder and Dr. Oliviero Bruni laud Slenyto® for its efficacy in improving sleep latency as well as sleep duration. This improvement in sleep also correlates with enhanced behavioral outcomes, showing a direct link to better quality of life for both the patients and their families.

Importance of the Approval

The recent approval opens up a new chapter for many families grappling with the complex interplay of ADHD and sleep disorders. By providing a more robust treatment option, Slenyto® aims to alleviate the stresses associated with sleepless nights for children diagnosed with ADHD. This is a critical advancement in pediatric healthcare, underscoring the necessity of targeted treatments that cater to the specific needs of vulnerable populations.

Conclusion

As Neurim Pharmaceuticals moves forward, it continues to focus on developing innovative treatments in the field of neuroscience. With the approval of Slenyto® for ADHD-related insomnia, the company stands at the forefront of pediatric sleep medicine. Families can now find hope in a therapeutic option specifically designed to address the challenges of sleep disorders that accompany ADHD, while also enhancing the overall quality of care for children with these complex conditions.

For more information on Slenyto® and its implications, visit Neurim Pharmaceuticals' website.